Edge Therapeutics announced today positive preliminary results from the first human use of EG-1962, the Company's novel bioabsorbable nimodipine microparticle formulation for the prevention of delayed cerebral ischemia (DCI), a life-threatening complication of subarachnoid hemorrhage (SAH), typically resulting from a ruptured brain aneurysm or traumatic brain injury. There are approximately 90,000 patients in North America and Europe who are at risk for DCI, most of whom would be candidates for EG-1962.
“Despite efforts to prevent DCI, many patients continue to suffer a secondary stroke or even death 3 to 14 days after their hemorrhage”
Researchers at Heinrich-Heine-University Hospital in Düsseldorf, Germany conducted an open-label study to assess the safety and tolerability of EG-1962, which delivers therapeutic and sustained concentrations of nimodipine directly to the site of brain injury. Eleven patients were treated and 10 met pre-defined enrollment criteria, which included a low level of consciousness on admission to the emergency room and high hemorrhage volumes. Investigators found that there were no adverse events or other safety concerns related to EG-1962. Additionally, good clinical outcome, as measured by the Glasgow Outcome Scale (GOS) 30 days after SAH, was observed in all 10 patients who met the enrollment criteria. Based on similar patients treated in past clinical studies, researchers would have expected approximately half of these patients to suffer a poor outcome, such as death, persistent vegetative state or severe disability. An oral presentation of these data is scheduled during Vasospasm 2013, the 12th International Conference on Neurovascular Events after Subarachnoid Hemorrhage, on Fri., July 12, 2013 in Lucerne, Switzerland.
"Our early clinical experience shows that one-time administration of EG-1962 has the potential to prevent a major cause of death or permanent disability after SAH," said Daniel Hänggi, M.D., principal investigator of the study and Vice Chairman of the Department of Neurosurgery at Heinrich-Heine-University. "We are eager to participate in further research to investigate this promising and potentially life-saving therapy in our new investigator-initiated study under the auspices of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, the German Institute for Drugs and Medical Devices)."
"The early clinical results and lack of side-effects with EG-1962 are striking," noted R. Loch Macdonald, M.D., Ph.D., Head of the Division of Neurosurgery and Keenan Endowed chair in Surgery at St. Michael's Hospital in Toronto, Ontario, Canada, and Chief Scientific Officer of Edge Therapeutics. "Given these positive early results, EG-1962 may provide physicians with a powerful tool to reduce the risk of poor outcomes that threaten these already vulnerable patients."
Nimodipine is the standard of care for the prevention of DCI worldwide. However, many researchers believe currently approved oral and intravenous formulations of nimodipine deliver sub-optimal concentrations to the site of brain injury and have shown only modest efficacy in reducing poor outcomes after aneurysmal SAH. Previous efforts to administer higher doses of nimodipine have been limited by serious side effects such as hypotension.
"Despite efforts to prevent DCI, many patients continue to suffer a secondary stroke or even death 3 to 14 days after their hemorrhage," said Brian Leuthner, President and CEO of Edge Therapeutics. "The average age of patients who develop DCI is 50 years old and their complications are often catastrophic. There have been no approved therapies for DCI in almost 25 years, and we are hopeful that EG-1962 might one day become a new treatment option for these patients."
Edge announced earlier this month that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for EG-1962. The opening of the lND will allow the company to begin enrolling patients in a Phase 1/2 clinical trial evaluating the safety and tolerability of EG-1962 for prevention of DCI. The multinational Phase 1/2 trial, expected to commence in the third quarter of 2013, is to be conducted separately from the Heinrich-Heine-University investigator-initiated study, and will include up to 96 patients in approximately 20 centers in North America and Europe.